Dental Implantation Clinical Trial
Official title:
Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study
Verified date | October 2020 |
Source | Saint-Joseph University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | December 30, 2020 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patient age: between 20 and 65 - No systematic contraindication for implant surgery - No more than 10 cigarettes/day - Previous horizontal bone augmentation 6 months prior to implant placement - Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%) Exclusion Criteria: - Smokers more than 10 cigarettes/day - Pregnant/lactating women - Alcoholics/drug addicts - Uncontrolled diabetics, immunocompromised, blood hemostasis problems - Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing - Patients not willing to sign the consent form - History of radiotherapy in the head and neck region in the last 5 years - Active periodontitis on the remaining teeth |
Country | Name | City | State |
---|---|---|---|
Lebanon | Saint-Joseph University | Beirut |
Lead Sponsor | Collaborator |
---|---|
Saint-Joseph University |
Lebanon,
Donati M, Ekestubbe A, Lindhe J, Wennström JL. Marginal bone loss at implants with different surface characteristics - A 20-year follow-up of a randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):480-487. doi: 10.1111/clr.13145. Epub 2018 Mar 23. — View Citation
Esposito M, Ardebili Y, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2014 Jul 22;(7):CD003815. doi: 10.1002/14651858.CD003815.pub4. Review. — View Citation
Koller CD, Pereira-Cenci T, Boscato N. Parameters Associated with Marginal Bone Loss around Implant after Prosthetic Loading. Braz Dent J. 2016 May-Jun;27(3):292-7. doi: 10.1590/0103-6440201600874. — View Citation
Liu J, Kerns DG. Mechanisms of guided bone regeneration: a review. Open Dent J. 2014 May 16;8:56-65. doi: 10.2174/1874210601408010056. eCollection 2014. — View Citation
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Rosa MB, Albrektsson T, Francischone CE, Schwartz Filho HO, Wennerberg A. The influence of surface treatment on the implant roughness pattern. J Appl Oral Sci. 2012 Sep-Oct;20(5):550-5. — View Citation
Shi JY, Jie-Ni, Zhuang LF, Zhang XM, Fan LF, Lai HC. Peri-implant conditions and marginal bone loss around cemented and screw-retained single implant crowns in posterior regions: A retrospective cohort study with up to 4 years follow-up. PLoS One. 2018 Feb 5;13(2):e0191717. doi: 10.1371/journal.pone.0191717. eCollection 2018. — View Citation
Testori T, Wiseman L, Woolfe S, Porter SS. A prospective multicenter clinical study of the Osseotite implant: four-year interim report. Int J Oral Maxillofac Implants. 2001 Mar-Apr;16(2):193-200. — View Citation
Wennerberg A, Hallgren C, Johansson C, Danelli S. A histomorphometric evaluation of screw-shaped implants each prepared with two surface roughnesses. Clin Oral Implants Res. 1998 Feb;9(1):11-9. — View Citation
Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennström JL, Chierico A, Stach RM, Kenealy JN. A prospective, multicenter, randomized-controlled 5-year study of hybrid and fully etched implants for the incidence of peri-implantitis. J Periodontol. 2010 Apr;81(4):493-501. doi: 10.1902/jop.2009.090492. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline of alveolar ridge thickness at 4 months | Peroperative surgical measurements of the alveolar ridge width at implant sites | During procedure and at 4 months | |
Primary | Change from baseline of radiographic bone level on CBCT at 1 year post-op | CBCT for buccal bone thickness measurements of the bone crest width at the implant site. | During procedure and at 1 year | |
Primary | Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray | Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact | During procedure, at 4 months, at 6 months and 1 year | |
Primary | Change from baseline of bone plate thickness at 4 months | Peroperative buccal and lingual residual bone thickness following implant insertion | During procedure and at 4 months | |
Secondary | Insertion torque | Manual torque insertion are registered at implant placement. | During procedure | |
Secondary | Change of Clinical parameters from baseline to 1 year post-op | FMBS, FMPS, | During procedure, at 6 months and at 1 year | |
Secondary | Change of FMBS parameters from baseline to 1 year post-op | Change in full mouth bleeding score | During procedure, at 6 months and at 1 year | |
Secondary | Change of Keratinized tissue height from Baseline to 4 months | Measured using a 1.0-mm marked periodontal probe | During procedure and at 4 months | |
Secondary | Histological analysis | Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality | During procedure | |
Secondary | Change of FMPS parameters from baseline to 1 year post-op | Change in full mouth plaque score | During procedure, at 6 months and at 1 year |
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